Trial Outcomes & Findings for Efficacy and Safety Study of Uracyst to Treat Interstitial Cystitis/Painful Bladder Syndrome (NCT NCT00919113)
NCT ID: NCT00919113
Last Updated: 2013-05-03
Results Overview
subjects that indicated "markedly improved" or "moderately improved" on the GRA, LOCF
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
98 participants
Primary outcome timeframe
at week 11
Results posted on
2013-05-03
Participant Flow
Participant milestones
| Measure |
Uracyst
2% sodium chondroitin sulfate
|
Placebo
identical buffer
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
48
|
|
Overall Study
Received Uracyst
|
49
|
0
|
|
Overall Study
Received Placebo
|
0
|
49
|
|
Overall Study
COMPLETED
|
41
|
40
|
|
Overall Study
NOT COMPLETED
|
9
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety Study of Uracyst to Treat Interstitial Cystitis/Painful Bladder Syndrome
Baseline characteristics by cohort
| Measure |
Uracyst
n=49 Participants
2% sodium chondroitin sulfate
|
Placebo
n=49 Participants
identical buffer
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Age Continuous
|
44.4 years
STANDARD_DEVIATION 14.6 • n=99 Participants
|
46.8 years
STANDARD_DEVIATION 14.1 • n=107 Participants
|
45.6 years
STANDARD_DEVIATION 14.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=99 Participants
|
49 participants
n=107 Participants
|
98 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: at week 11Population: Efficacy analysis performed according to randomized treatment.
subjects that indicated "markedly improved" or "moderately improved" on the GRA, LOCF
Outcome measures
| Measure |
Uracyst
n=50 Participants
2% sodium chondroitin sulfate
|
Placebo
n=48 Participants
identical buffer
|
|---|---|---|
|
Global Response Assessment (GRA) Responders at Week 11.
|
19 participants
|
15 participants
|
SECONDARY outcome
Timeframe: at week 11Population: Efficacy analysis performed according to randomized treatment.
Subjects that exhibited at least a 30% improvement from baseline in their total ICSI score, LOCF
Outcome measures
| Measure |
Uracyst
n=50 Participants
2% sodium chondroitin sulfate
|
Placebo
n=48 Participants
identical buffer
|
|---|---|---|
|
Interstitial Cystitis Symptom Index (ICSI) Responders at Week 11.
|
23 participants
|
18 participants
|
Adverse Events
Uracyst
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Uracyst
n=49 participants at risk
2% sodium chondroitin sulfate
One subject was misrandomized. Actual treatment was used for Demographic and Safety analysis.
|
Placebo
n=49 participants at risk
identical buffer
One subject was misrandomized. Actual treatment was used for Demographic and Safety analysis.
|
|---|---|---|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
2.0%
1/49 • Number of events 1
|
0.00%
0/49
|
|
Gastrointestinal disorders
Colitis
|
2.0%
1/49 • Number of events 1
|
0.00%
0/49
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/49
|
2.0%
1/49 • Number of events 1
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/49
|
2.0%
1/49 • Number of events 1
|
Other adverse events
| Measure |
Uracyst
n=49 participants at risk
2% sodium chondroitin sulfate
One subject was misrandomized. Actual treatment was used for Demographic and Safety analysis.
|
Placebo
n=49 participants at risk
identical buffer
One subject was misrandomized. Actual treatment was used for Demographic and Safety analysis.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
16.3%
8/49
|
6.1%
3/49
|
|
Renal and urinary disorders
Dysuria
|
12.2%
6/49
|
8.2%
4/49
|
|
Psychiatric disorders
Headache
|
2.0%
1/49
|
12.2%
6/49
|
|
Gastrointestinal disorders
Nausea
|
8.2%
4/49
|
6.1%
3/49
|
|
Renal and urinary disorders
Cystitis Interstitial
|
4.1%
2/49
|
8.2%
4/49
|
|
Renal and urinary disorders
Urinary Tract Infection
|
8.2%
4/49
|
4.1%
2/49
|
|
Renal and urinary disorders
Bladder Pain
|
8.2%
4/49
|
2.0%
1/49
|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/49
|
8.2%
4/49
|
Additional Information
Gary Hoel, RPh PhD, VP Global Brands Clinical Research
Watson Laboratories, Inc.
Phone: 801 588-6641
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60